Author + information
- Kevin R. King, MD, PhDa,b,
- Luanda P. Grazette, MD, MPHc,
- Dina N. Paltoo, PhD, MPHd,
- John T. McDevitt, PhDe,
- Samuel K. Sia, PhDf,
- Paddy M. Barrett, MDg,
- Fred S. Apple, PhDh,
- Paul A. Gurbel, MDi,
- Ralph Weissleder, MD, PhDb,
- Hilary Leeds, JDd,
- Erin J. Iturriaga, MSNj,
- Anupama K. Rao, MDj,
- Bishow Adhikari, PhDj,
- Patrice Desvigne-Nickens, MDj,
- Zorina S. Galis, PhDj and
- Peter Libby, MDa,∗ ()
- aCardiovascular Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
- bMassachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
- cDivision of Cardiovascular Medicine, University of Southern California, Los Angeles, California
- dOffice of Science Policy, Office of the Director, National Institutes of Health, Bethesda, Maryland
- eDepartments of Bioengineering and Chemistry, Rice University, Houston, Texas
- fDepartment of Biomedical Engineering, Columbia University, New York, New York
- gScripps Translational Science Institute, La Jolla, California
- hHennepin County Medical Center and University of Minnesota, Department of Laboratory Medicine and Pathology, Minneapolis, Minnesota
- iInova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, Falls Church, Virginia
- jNational Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland
- ↵∗Reprint request and correspondence:
Dr. Peter Libby, Brigham and Women's Hospital, Harvard Medical School of Medicine, 77 Avenue Louis Pasteur, NRB 741, Boston, Massachusetts 02115-6110.
Point-of-care technologies (POC or POCT) are enabling innovative cardiovascular diagnostics that promise to improve patient care across diverse clinical settings. The National Heart, Lung, and Blood Institute convened a working group to discuss POCT in cardiovascular medicine. The multidisciplinary working group, which included clinicians, scientists, engineers, device manufacturers, regulatory officials, and program staff, reviewed the state of the POCT field; discussed opportunities for POCT to improve cardiovascular care, realize the promise of precision medicine, and advance the clinical research enterprise; and identified barriers facing translation and integration of POCT with existing clinical systems. A POCT development roadmap emerged to guide multidisciplinary teams of biomarker scientists, technologists, health care providers, and clinical trialists as they: 1) formulate needs assessments; 2) define device design specifications; 3) develop component technologies and integrated systems; 4) perform iterative pilot testing; and 5) conduct rigorous prospective clinical testing to ensure that POCT solutions have substantial effects on cardiovascular care.
Support for the Working Group was provided by the Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health (NIH). Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the National Heart, Lung, and Blood Institute or the National Institutes of Health. Dr. King has received the following grants: AHA 15MCPRP25690031, NIH-NHLBI 1K99HL129168, and Harvard Medical School LaDue Memorial Fellowship. Ms. Leeds, Ms. Iturriaga, and Drs. Paltoo, Rao, Adhikari, Desvigne-Nickens, and Galis are employees of the NIH. Dr. Grazette is a consultant for St. Jude, Amgen, and Relypsa; is an investigator for Novartis; and is a contractor for St. Jude. Dr. McDevitt serves as the scientific founder and has financial interests in LabNow and Force Diagnostics; and owns stock in SensoDx. Dr. Sia is a cofounder of Claros Diagnostics, acquired by OPKO Health. Dr. Barrett has received grant support from the U.S. NIH National Center for Advancing Translational Sciences (NCATS) grant (KL2TR000112). Dr. Apple has received grant support (nonsalaried) through the Minneapolis Medical Research Foundation, Abbott Diagnostics, Siemens, Ortho-Clinical Diagnostics, Roche Diagnostics, Radiometer, BRAHMS, Genentech, Arkray, BioMerieux, Alere, and Beckman Coulter; has been a paid consultant (<$10,000) for Instrumentation Laboratory T2 Biosystems and Philips Healthcare Incubator; and has served on the scientific advisory boards of Alere, Beckman Coulter, Instrumentation Laboratory, and Abbott Diagnostics. Dr. Gurbel has been a consultant for Daiichi Sankyo, Bayer, AstraZeneca, Boehringer Ingelheim, Merck, Medtronic, CSL, and Haemonetics; has received grant support from the NIH, Daiichi Sankyo, CSL, AstraZeneca, Coramed, Haemonetics, Medtronic, Harvard Clinical Research Institute, and Duke Clinical Research Institute; has been a speaker for Daiichi Sankyo and Merck; and holds a patent in personalized antiplatelet therapy in interventional cardiology. Dr. Weissleder is a founder of and consultant to T2Biosystems. Dr. Libby has received research support from the National Heart, Lung, and Blood Institute (R01 HL080472); has served as the Chair of this Working Group; is an unpaid consultant or involved in clinical trials for Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, DalCor, Genzyme, GlaxoSmithKline, Kowa, Merck, Novartis, Pfizer, Regeneron-Sanofi, and Takeda; and is a member of the scientific advisory boards for Athera Biotechnologies and Interleukin Genetics. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. King and Grazette contributed equally to this work.
- Received January 13, 2016.
- Accepted January 20, 2016.
- The Authors